NCT00553176

The Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry

Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,273 (actual)
• Sponsor: Janssen Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn's disease in real world medical practice.

Detailed description

The TREAT (The Crohn's Therapy, Resource, Evaluation, and Assessment Tool) registry is a prospective, observational, multicenter, long-term registry featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease. The physicians will track treatments and patient outcomes over at least a 5-year period. Physicians are expected to manage patients as they would under normal practice conditions. No predefined schedule of visits or medical procedures are required. Data are collected on a semi-annual basis by physicians documenting assessment of disease severity, medication use, and adverse events. Upon enrollment, patients complete a health assessment questionnaire. As this is an observational study, no study drugs are administered. Through the course of the Registry, analyses will be performed to support submissions to health authorities, and questions of academic interest.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
OTHER	No intervention	At six-month intervals (January and July), physicians will document disease characteristics, changes in Crohn's therapy, disease progression, key events, the use of ancillary services, and hospitalizations

Timeline

• Start date: 1999-08-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2007-11-05
• Last updated: 2013-03-04